“Uhmmm, hi everyone”
——————————————————————0:48:00
——————————————————————0:53:00
——————————————————————BB – “A every time that I and and and and, and David (James @StortSkeptic the Skeptic Canary) points this out, that um, you you know you’re not going to speculate about the the FDA but then at every turn you’re invoking the FDA as being obstructionist“
——————————————————————0:54:02
——————————————————————BB – “I, I just find that to be contradictory and and self-defeating“
======================================DJT – Bob, exactly where did I invoke “the FDA as being obstructionist” ?
======================================1:02:00
——————————————————————BB – “Um, it’s it’s it’s not the FDA’s, but you understand it’s not the FDA’s job to tell someone that their drug doesn’t work“
——————————————————————1:03:00
——————————————————————BB – “it’s it’s it’s up to Burzynski“

Oh, and Bob, exactly when did Burzynski 1st claim “this miracle cancer cure” ?
======================================1:04:02
——————————————————————BB – “Um, that we’d love to see, however we can’t see, however we can’t see it because of proti protri proprietary uh protections that the FDA is giving to Burzynski, right ?”

“They’re not sharing his trial designs because they are his trial designs, right ?”

“That the makeup of his drug that he’s distributing are his, uh design, and his intellectual property“

“So the FDA is protecting him, uh from outside scrutiny“
======================================DJT – Bob, you make it sound like it’s part of some grand “conspiracy” between Burzynski and the FDA to keep information from “The Skeptics™” [3]
——————————————————————
21CFR601

Subpart F–Confidentiality of Information

Sec. 601.50

Confidentiality of data and information in an investigational new drug notice for a biological product

(a) The existence of an IND notice for a biological product will not be disclosed by the Food and Drug Administration unless it has previously been publicly disclosed or acknowledged
======================================BB – “While you may imagine that that, that that the FDA is is somehow antagonistic toward him“

“They’ve given him every opportunity, over 60 opportunities to prove himself worth uh their confidence and hasn’t“
======================================DJT – Bob, that certainly explains the 9/3/2004 and .10/30/2008 ODD’s and phase 3 clinical trial approvals by the FDA – NOT [1-2]
======================================1:05:00
——————————————————————1:42:00
——————————————————————BB – “I don’t, the thing is though that, that that’s a inver, shifting the burden of proof off of Burzynski”

“Burzynski has to prove them wrong, has to prove him right”

“The FDA is not there to say this doesn’t work”
======================================DJT – Bob, who initiated and put into place the clinical trial hold ?

Burzynski ?

FDA ?

Both ?
======================================1:43:30
——————————————————————BB – “So, I mean, honestly, um, saying “Well, when the F, FDA tells you that it doesn’t work, the FDA’s never gonna say that because that’s not their job“
——————————————————————1:44:00
——————————————————————BB – “That’s not an option, because they’re never gonna do it“

“They relinquish, a lot of authority, over to Burzynski, and his Institutional Review Board, which, I would mention, has failed 3 reviews in a row”======================================Bob, where are the “final reports” for those “3 reviews” ?======================================BB – “Right ?”

“It is Burzynski’s job to be convincing”

“It is not our uh, uh, it it it he hasn’t produced in decades“

“In decades”

“In hundreds and hundreds of patients, who’ve payed to be on this”

“Hell, we’d we’d we’d like a prelim, well when you’re talking about something that is so difficult as brainstem glioma, that type of thing gets, really does in the publishing stream get fast-tracked there”
======================================DJT – Bob, Burzynski has provided numerous phase 2 clinical trial preliminary reports, which our #fave oncologist has chosen to ignore [4]
======================================BB – “they test it”

“Yeah, and they they they want uh, that was evidence of fast-tracking is what, that rejection was uh e was very quickly“
======================================DJT – Bob, have you checked The Lancet Oncology [5] to see what was so much more important than Burzynski’s “phase 2 clinical trial Progression-Free Survival (PFS) and Overall Survival (OS) re patients 8 – 16 years after diagnosis, results” [6] and the Japanese antineoplaston study ? [7]
======================================BB – “So, how long will it be before Burzynski doesn’t publish, that you decide that uh perhaps he’s he‘s, doesn’t have the goods ?“

“Um, so, uh, uh again, the FDA is not the arbiter of this“

“It’s ultimately Burzynski”

“You’ve been speculating about what the FDA’s motivation are like crazy”

“Why not speculate about Burzynski a little bit”
======================================DJT – Well, how have I been speculating ?
======================================1:46:00
——————————————————————BB – “Well actually I’m not even asking you to speculate about Burzynski, I’m only asking you to tell me, how long would it take, uh how, for him to go unpublished like this, um, for this long, before you would doubt it ?”======================================DJT – Note how, above, without proving it, Bob claimed “at every turn you’re invoking the FDA as being obstructionist”, and now, directly above, again, without proving it, Bob claims “You’ve been speculating about what the FDA’s motivation are like crazy”——————————————————————DJT – what the journals keep saying, in response
======================================BB – “What ?”
======================================DJT – You know, are they going to give The Lancet response, like they did in 2 hours and such, saying, “Well, we think your message would be best heard elsewhere,”or they gonna gonna give The Lancet response of, “Well, we don’t have room in our publication this time, well, because we’re full up, so, try and pick another place”?
======================================BB – “But these but but but that doesn’t have any bearing on“

“That doesn’t”

“Oh I’m not asking you how long, how long, would it take you for you to start doubting whether or not he has the goods ?“

“How long would it take ?”

“It’s a it’s a it’s a question that should be answered by a number uh uh months ?“

“Years ?”

“How long ?”

“It’s been 15 years already”
======================================DJT – Well, you like to jump up and down with the “15 year” quote, but then again I always get back to, Hey, it’s when, when the report, when the clinical trial is done
——————————————————————1:47:06
——————————————————————DJT – Not that he’s been practicing medicine medicine for 36 years, or whatever, it’s when the clin, clinical trial was done
======================================BB – “I could push it back to 36 years”

“He hasn’t shown that it works for 36 years”

“I can do that”

“I was being nice”======================================DJT – Note how Bob acts like he’s been hit with “The Stupid Stick”

If he wants to go back “36 years”, I can refer back to 1991 (11/15/1991) – Michael J. Hawkins, M.D., Chief, Investigational Drug Branch, Department of Health &Human Services (HHS), Public Health Service, National Institutes of Health (NIH), National Cancer Institute (NCI), sent a 1 page Memorandum Re:
Antineoplaston to Decision Network, which advised, in part:

“It was the opinion of the site visit team that antitumor activity was documented in this best case series and that the conduct of Phase II trials was indicated to determine the response rate”[8]——————————————————————DJT – The FDA A believes there is evidence of efficacy
======================================BB – “Perhaps based on bad phase 2”
======================================DJT – Well, we don’t know that

We don’t have the Freedom of Information Act information——————————————————————DJT – Remember, Bob is the one who told me during the 9/28/2013 Google+ Burzynski Discussion Hangout:

“You’re you’re you’re assuming”

“You’re you’re you’re assuming that”

“You’re assuming that”

“Um, I’m not assuming that”

“There is a correct answer here”

“You don’t know”

“You don’t know”

“You need to look into it”

“Alright ?”

“Before you dismiss it you have to look into it”

“Everytime somebody throws uh uh something to me,I have to look into it”

“That’s just, it’s my responsibility as a reader”

“T t and what I would honestly expect and hope, is that you would be honest about this, to yourself, and and and that’s the thing we don’t, we often don’t realize that we’re not being honest with ourself“

“I try to fight against it, constantly”

Bob just ASSUMED that the FDA approved phase 3 clinical trials for Burzynski “Perhaps based on bad phase 2”, but tells me NOT to ASSUME ?======================================BB – “He withdrew”

“He withdrew the the phase 3 clinical trial”

“I that before recruiting,
although I’ve seen lots of people say they were on a phase 3 clinical trial“

“I wonder how that happened”
======================================DJT – Well, we know what happened in the movie because Eric particularly covered that when they tried to get what, what, was it 200 or 300 something institutions to take on a phase 3, and they refused
======================================1:48:01
——————————————————————BB – “Uh did do do you think that if they thought that he was a real doctor that they all would have refused like that ?“
======================================DJT – Well, Eric gave the reasons that they said they would not take a particular uh phase 3

And so using that excuse that you you just gave there, I’m not even gonna buy that one, because that’s not one of the reasons——————————————————————Note how Bob pulls out the old “if they thought that he was a real doctor” line ?

Is Bob now claiming that Burzynski is NOT even a “real doctor” ?======================================BB – “He’s changed things”
======================================DJT – Eric said they gave
======================================BB – “That The Lancet is a top-tier journal like New England Journal of Medicine“

“Um, it’s just, you know, let’s say he, someone has such a thin publishing record as Burzynski does, do you think that it’s likely that he will ever get in a top-tier journal ?“

“What about the the Public Library of Science?”

“It’s not the only journal there”

“What about BMC Cancer ?”

“There’s lots of places that he can go”
======================================DJT – We’ll I’m
======================================BB – “Um, and he doesn’t seem to to have evailed himself of that, as far as I can tell“

“And I would know because he’d get rejected, or he’d be crowing, you know”
——————————————————————1:49:02
——————————————————————BB – “Either way, he’s gonna tell us what happens”

“He told us what happened with The Lancet, you know”

“I don’t have any evidence that suggests to me that he’s even trying”======================================Note how Bob refers to Burzynski’s numerous publications as “such a thin publishing record”

Bob, do I need to count all of these for you ? [9]——————————————————————DJT – Well, I’m, I’m sure that they’re going to keep you appraised just like they have in the past, just like Eric has done in the past

So

I mean, we’ll see what happens with the Japanese study [7]
======================================BB – “So let’s go back to this”

“How long will it take ?”

“How long will it take before you, the Japanese study’s interesting too because we should be able to find that in the Japanese science databases, and we can find, we can’t find it at all“

“We can’t find it anywhere”

“And, and those are in English, so it’s not a language problem“

“We can’t find that anywhere”

“We’ve asked”

“We asked Rick Schiff, for, for that study”

“And, and it hasn’t come to us“

“He is now I believe on the Board of Directors, over there”
——————————————————————1:50:00
——————————————————————BB – “He should have access to this”

“We can’t get it”
======================================Bob, did you ask:

4. Kurume University School of Medicine (Japan) Department of Surgery ?

5. Hideaki Tsuda ? [7]
======================================BB – “How how long will it take before you recognize that, nothing is forthcoming ?”

“How long would that take ?”
======================================DJT – Well that’s like me asking “How long is it going to take for y’all’s, y’all‘s Skeptics to respond to my questions ?”

Because y’all haven’t been forthcoming
======================================BB – “Well, I mean, were talking about a blog here“

“We’re talking about life”

“No, we’re talking about a blogger’s feelings in that case“

“In in this case we’re talking about, 1,000′s of patients, over the course of of of generations, you know”

“This is important stuff”

“This is not eh eh equating what’s happening to to patients with what’s happening to you is is completely off-kilter as far as I can tell“

“It’s nothing”

“It’s nothing like you not getting to say something on my web-site”

“You know”

“This is they they have thrown in with Burzynski, and they’ve trusted him, and he’s produced nothing“

“Nothing of substance”
——————————————————————1:51:00
——————————————————————BB – “Nothing that that has made all of that um, uh, n nothing th th th that uh his peers would take seriously”

“The other thing that that that strikes me now is that, you know, you you you you keep saying that, well Eric is going to to share things with you”

“Does it ever concern you eh uh eh occur to you that Eric might not be reliable ?”======================================Bob, do you want to have a contest to determine which of you is more “reliable” ?======================================DJT – Well, he gave you The Lancet information and he posted the e-mail in the movie, and Josephine Jones posted a copy of it [6]
======================================BB – “He then, and then he”

“And then he he, you know, the the the the dialogue that sprung up around that was, well see, he’s never going to get to get published”

“Well you’re just setting yourself up for wish fulfillment”

“You want him to be, persecuted, so you are ecstatic when he doesn’t get to publish, which is unfortunate for all the cancer patients, who really thought that one day, all the studies were going to be published”
——————————————————————1:52:00
======================================DJT – Well, y’all are free to, you know, claim that all you want, because I don’t always agree with Eric, and uh, he’s free to express his opinion
======================================BB – “Where has Eric been wrong ?”
======================================DJT – Well I don’t necessarily believe, what Eric would say about, you know, The Lancet that refused to publish the 2nd one, for the reasons he stated, and which y’all have commented on, including Gorski

You know, I don’t necessarily agree with that

I am more agreeable to y’all, saying that, you know, they’re busy, they’ve got other things to do, but I’m kind of still laughing at their 1st response which he showed in the movie about how they felt about, you know his results would be better in some other publication

I thought that was kind of a ridiculous response to give someone
======================================BB – “It’s it’s it’s it’s a form letter“

“You know”

“They’re just saying, “No thanks””

““Thanks, but no thanks” is what they were saying, in the most generic way possible”

“Like I said, they’re besieged by researchers trying to publish“
——————————————————————1:53:05
======================================DJT – Well you would think that if its a form letter they would use the same form that they used the 2nd time

You know, they didn’t use the same wording that they used the 1st time

I would have think that, you know, their 2nd comment
======================================BB – “So, so, possibly”

“So possibly what you are saying is that they in fact have read it, and after having read it they’ve rejected it”

“Is that what you’re saying ?”

“Because that’s what peer-review is”
======================================DJT – Nah, I’m not saying that they did that all

I’m just sayin’, you know, that they gave, 2 different responses, and I would think that the 2nd one they gave
======================================BB – “Do you know it was the same editor, that it came from the same desk ?”

“You can’t make that assumption that that the form letter will be the same form letter every time”

“I mean you just can’t“

“I mean in in some ways we have a lot of non-information that you’re filling in, with what you expect, as as opposed to what’s actually really there, and I I I just think you’re putting too much uh stock in one uh, uh, in in in in this uh the publication kerfuffle“
——————————————————————1:54:16
——————————————————————BB – “Um”
======================================DJT – Well I find it funny, something along the lines of, you know, “We believe your message would be received better elsewhere, you know

I don’t see that as a normal response, a scientific publication would send to someone trying to publish something

I mean, to me that sounds, like, if you’re doing that, and you’re The Lancet Oncology, maybe you need to set some different procedures in place, ‘cuz you would think that with such a great scientific peer-reviewed magazine, that they would have structured things in as far as how they do their operations
======================================BB – “Well, not necessarily“

“I’ve been in any # of professional groups where the organization is just not optimal, and publications certainly th there are all sorts of pressures from all sorts of different places”
——————————————————————1:55:08
——————————————————————BB – “I I have no problems whatsoever with seeing that this might not be completely uh um uh streamlining uniform processes as possible“

“The fact that it’s not uniform, doesn’t have anything to do with Burzynski not publishing, not producing good data”

“Not just going to a, you know, god, even if, even if, let’s put it this way, even if he went to a pay to play type publication where you have to pay in order to get your manuscript accepted; and he has the money to do this, it wouldn’t take that much, and he were to put out a good protocol, and he were to show us his data, and he would make his, his his stuff accessible to us, then we could validate it, then we could look at it and say, “Yeah, this is good,” or “No, this is the problem, you have to go back and you have to fix this””

“Right ?”

“So we really, every time we talk about the letter that he got, yeah that doesn’t have much to do with anything, really”
——————————————————————1:56:02
——————————————————————BB – “We wanna see the frickin’ data”

“And if he had a cure for some cancers that otherwise don’t have reliable treatments, he has an obligation to get that out there anyway he can“

“And if if peer-review doesn’t, you know, play a, if peer-review can’t do it, you know, isn’t fast enough for him, then he should take it to the web, and he should send copies out to every pediatric, uh, you know, oncologist that there is“

“That’s the way to do it”
======================================DJT – Well, I’m sure, I’m sure Gorski would have a comment about that, as he’s commented previously about how he thinks uh Burzynskishould publish
======================================1:57:10
——————————————————————BB – “It’s the, it’s the data itself“

“If if Burzynski is is, is confident in his data, he will put it out there“

“Right ?”

“One way or the other”
======================================DJT – Like I said before

Like I said before on my blog, you know, even if Burzynski publishes his phase 2 information, Gorski can just jump up and down and say, “Well, that just shows evidence of efficacy, you know, it’s not phase 3,so it doesn’t really prove it”
——————————————————————1:58:04
——————————————————————DJT – So then he can go on, you know, for however many years he wants to
======================================2:01:00
——————————————————————BB – “Um, almost no treatment goes out without trials“

“Massive amounts of data are required”======================================Bob, do you think that’s the 2.5 million pages of clinical trial data that Fabio said Burzynski sent to the FDA ? [10]======================================2:02:00
——————————————————————BB – “Uh, in in in that sense, you know, uh all the the the, you know, kind of back-peddling and and and trying to defend him is is going to, not going to help his case at all“
======================================Bob, exactly where did I exhibit any “kind of back-peddling” ?
======================================2:03:03
——————————————————————
BB – “You are, honestly as far as I can tell you are doing the um, you know, you’re you’re ah throwing up uh, uh, uh, you’re giving me another uh invisible dragon in the garage, um”
======================================DJT – Well y’all, y’all can call things what y’all want

I mean, y’all can give these, fallacy arguments and all that garbage that y’all like, because that’s what y’all like to talk about instead of dealing with the issues

“What you’re telling me is that you trust the FDA to to be able to tell you when he’s not doing, good science, but also that you don’t trust the FDA”

“Do you see an inherent conflict there ?”
======================================DJT – How did I say I, I didn’t trust them ?
======================================BB – “Well, when I, whenever I would ask about, like, why would these trials aren’t happening uh and, you know, you say well the the FDA’s arranged it“

“The FDA’s in control”

“They sign off on these things”

“But they’re they’re they’re they’re at the same that they’re, they’re trustworthy they’re also not trustworthy depending on what you need for the particular argument at the time“
——————————————————————2:05:12
——————————————————————BB – “You’re suggesting that they’re untrustworthy”
======================================DJT – No, I’m just sayin’ that I’ve raised questions and none of The Skeptics wanna to uh talk about ‘em [11]
======================================BB – “Do you know that the FDA pulled out of the prosecution ?”

“Did you know that the FDA pulled out of the prosecution um of his criminal case, because they were backing a researcher ?”======================================Bob, would that “researcher” be Dvorit D. Samid, who was in Burzynski: Cancer is Serious Business (Part I) ?——————————————————————DJT – Well, we know a lot stuff they did, but that still doesn’t impress me that they pulled out of the prosecution

I mean
======================================BB – “Yeah, the the the it wasn’t the FDA who was pressing charges, it was a Federal prosecutor“
======================================DJT – Right
======================================BB – “Right”

“And and, they declined to provide information that the prosecution needed“

“That’s important”

“That that that’s really important“

“That he has been given the benefit of the doubt, and he has come up wanting, for decades now”
======================================DJT – Well I find it interesting a lot of this uh, a lot of these letters that were provided between, you know, the government and Burzynski, when the uh phase 2 study was going on, at the behest of the NCI

You know, anybody who reads that stuff knows, that when you just ignore the person that’s been doing, do treating their patients for 20 something years, or close to 20 years, and you change the protocol without his approval, and you don’t use the drugs in the manner that he knows works
======================================2:10:15
——————————————————————BB – “One of the interesting things about Doubting Thomas that I think you should definitely consider for yourself, is that at some point, when faced with the real opportunity to prove or disprove his assertions, he doubted himself”

“And that’s important”

“And that’s where you’re falling short in the analogy”
======================================DJT – Well, I think The Skeptics, Skeptics are falling short because, you know, they don’t own up to
======================================BB – “I’ve laid out exactly what it would take for me to turn on a fucking dime”

“I have, I have made it abundantly clear what I need“

“Gorski has made it abundantly clear”

“Everybody else, Guy, and David, and Josephine Jones, uh, the Morgans, all of them have made it abundantly clear, what it would take to change our minds, and you’ve never done that”
——————————————————————2:11:02
——————————————————————BB – “And even in this, this was an opportunity to do that“

“To come up with a basis for understanding, where it’s like, you know what, If we can show this, you know, if we can show a this guy, that, that, there, that his standards are not being met, then, you know, we could possibly have some sort of ongoing dialogue after this”
======================================DJT – So I can say that since the Mayo Clinic (Correction: M.D. Anderson) finished their study in 2006, and it took them until 2013, to actually publish it, then I can say, well, Burzynski finished his in 2009, which was 3 years later, which would give Burzynski until 2016
======================================BB – “Why wasn’t that study”
======================================DJT – for me to make up my mind (laughing)
======================================BB – “Why wasn’t that, that that that, still . . again, it it doesn’t seem really to to approach the the the, main question here“

“You know, um . . what are the standards that you have that it isn’t, what are your standards to show that it isn’t efficacious ?“
——————————————————————2:12:05
======================================DJT – Well I can say, well I’m going to have to wait, the same amount of time I had to wait for Mayo (Correction: M.D. Anderson) to publish their study; which was from 2006 to 2013
======================================BB – “Why was the Mayo”

“Why was the Mayo (Correction: M.D. Anderson) study delayed ?”======================================Note how Bob ASSUMES that the publishing of the final results of the M.D. Anderson study were delayed——————————————————————DJT – How do you know it was delayed ?
======================================BB – “Well you said you had so many years before you finish it and go in”
======================================DJT – I mean, has anybody
======================================BB – “Why, why did it take so long ?“
======================================DJT – done a review of when a clinical trial is studied, and completed, and how long it took the people to publish it ?

You know

If they could point to me a study that’s done that, and say, well here’s the high end, here’s the low end of the spectrum, here’s the middle
======================================BB – “I have something for you, okay ?”

“Send me that”

“Could you send me that study the way that it was published because um, just just send me the final study, um, to my e-mail address”
======================================DJT – Sure
======================================BB – “Um, because, I can ask that question of those researchers, why was this study in this time, and what happened in-between”
——————————————————————2:13:03
——————————————————————BB – “Why did it take so long for it, for it to come out”
======================================DJT – Sure, but that’s not gonna, you know like, answer an overall question of, you know, somebody did a comparative study of all clinical trials, and, when they were finished, and at, and when the study was actually published afterwards

“Um, but it it would, perhaps, answer the question; because you’re using it as an example on the basis of which to dismiss criticism, whether or not, uh, it is the standard, and therefor you’re allowed to accept that Burzynski hasn’t published until 2016, or, um, it’s an anomaly, which is also a possibility, that most stuff comes out more quickly“
======================================DJT – Well, we know that the Declaration of Helsinki doesn’t even give a standard saying, “You must publish within x amount of years,” you know ?

So, I’ve yet to find a Skeptic who posted something that said, “Here are the standards, published here”
======================================2:14:07
——————————————————————BB – “I I, yeah, the other thing that David James points out is you know, why 2016 when he’s had 36 years already ?“
======================================DJT – Again, we get back to, when the clinical trial is finished, not when Burzynski started
======================================BB – “Treating people”
======================================DJT – I mean, you would expect to find a results to be published after, the final results are in
======================================BB – “You would expect the Burzynski Patient Group to be a lot bigger after 36 years, and in fact is
======================================DJT – You would expect some people would want to have confidentiality, and maybe not want to be included
======================================BB – “So, if you’re unsure about this stuff, if you’re unsure about the the time to publication, why are you defending it so hard, other than saying, “I don’t know, I really need to”
======================================DJT – Why am I unsure ?
======================================BB – “Uh about the
======================================DJT – (laughing) I just gave you an example
======================================BB – “The reasons, the reasons for which that he’s, no, why are you defending him so hard, when you’re unsure ?
——————————————————————2:15:02
======================================DJT – Oh, who said I was unsure ?

I just gave you an example
——————————————————————Note how Bob ASSUMES that I’m “unsure” when I had the same answer since 0:32:07 [12]